Overview

Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open label, randomised, 2-way crossover, comparative bioequivalence study.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Desloratadine
Ephedrine
Loratadine
Pseudoephedrine
Criteria
Inclusion Criteria:

- Is the individual a healthy, normal adult man or woman who volunteers to participate?

- Is s/he within 18 to 45 years of age, inclusive?

- Is his/her BMI between 19 and 30 inclusive?

- Is she willing to avoid pregnancy by abstaining from sexual intercourse with a
non-sterile male partner, or by the use one of the following methods: diaphragm +
spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine
contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or
has she been surgically sterile or post-menopausal at least six months prior to
entering into the study?

- Is s/he considered reliable and capable of understanding his/her responsibility and
role in the study?

- Has s/he provided written informed consent?

Exclusion Criteria:

- Does the individual have a history or allergy or hypersensitivity to desloratadine or
pseudoephedrine, milk or eggs?

- Does s/he have clinically significant laboratory abnormalities that would interfere
with the conduct or interpretation of the study or jeopardize his/her safety?

- Does s/he have significant history or clinical evidence of auto-immune,
cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological,
ongoing infection, pancreatic, or renal disease that would interfere with the conduct
or interpretation of the study or jeopardize his/her safety?

- Is she nursing?

- Does s/he have serious psychological illness?

- Does s/he have significant history (within the past year) or clinical evidence of
alcohol or drug abuse?

- Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C
screen, or a positive pregnancy test?

- Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or
beverages during periods beginning 48 hours prior to study drug administration and
ending when the last blood sample has been taken in each study period?

- Has s/he used any prescription drug, other than hormonal contraceptives, during the 14
day period prior to study initiation, or any OTC drug during the 72 hour period
preceding study initiation?

- Is s/he unable to refrain from the use of all concomitant medications, other than
hormonal contraceptives, during the study?

- Has s/he donated or lost blood or participated in a clinical study which involved the
withdrawal of a large volume of blood (480 mL or more), during the six week period
preceding study initiation?

- Has s/he donated plasma during the two week period preceding study initiation?

- Has s/he received an investigational drug during the 30 day period preceding study
initiated?

- Has s/he used any tobacco products in the 3 months preceding drug administration?